US2002115991A1PendingUtilityA1

Gerd treatment apparatus and method

43
Assignee: CURON MEDICAL INCPriority: Jun 24, 1994Filed: Jul 24, 2001Published: Aug 22, 2002
Est. expiryJun 24, 2014(expired)· nominal 20-yr term from priority
Inventors:Stuart D. Edwards
A61B 18/00A61B 2090/3614A61B 2018/1253A61M 25/1002A61B 2018/00898A61B 2018/00875A61B 2017/00106A61B 2018/1425A61B 18/1206A61B 2018/126A61B 2018/00797A61B 2018/00821A61B 18/1492A61B 2017/003A61B 2018/00916A61B 2018/00702A61B 2018/0262A61B 18/08A61B 2018/124A61M 16/0459A61B 2018/00577A61B 2018/00029A61N 7/02A61B 2018/00738A61B 2018/00869A61B 18/1485A61B 2017/00084A61B 2090/3966A61B 2018/00982A61M 2025/1086A61B 2018/0022A61B 2090/3782A61B 2018/00666A61B 2018/00678A61B 18/1815A61B 2018/00107A61B 2018/00791A61B 2018/00886A61B 2018/00744A61B 2018/0091A61B 2018/00077A61B 2017/00867A61B 2018/00708A61B 2018/00494A61B 2018/00065A61N 1/056A61B 2018/00839A61B 2018/00267A61B 2018/00815A61M 2025/1052A61B 2017/22062A61B 2218/002A61B 2018/1472A61B 2018/00726A61B 2018/0016A61B 2018/00023A61B 2018/00559A61B 2018/00755A61B 18/148A61B 2018/00148A61B 2017/22072A61B 2018/00827A61B 2018/00892A61N 1/40A61B 2018/046A61B 18/1477A61B 2018/1273A61B 2017/00022A61N 1/06A61B 2018/00761A61B 2018/1467A61B 2018/00083A61B 2018/00113A61B 2017/4216A61B 2018/00553A61M 16/0454A61M 16/0481A61B 2018/00214A61B 18/18A61B 2018/00654A61B 2018/00011A61F 7/12C08L 2201/12
43
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Claims

Abstract

An apparatus includes an expandable member. The expandable member is sized to be positionable in a sphincter. An energy delivery device is positioned on a surface of the expandable member. The energy delivery device has a configuration that provides sufficient energy delivery to create lesions in the interior of the sphincter. When the expandable member is removed from the sphincter, the sphincter returns to its closed or contracted configuration.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         1 . An apparatus, comprising: 
 an expandable member being sized to be positionable in a sphincter; and    an energy delivery device coupled to the expandable member, the energy delivery device having a configuration that controllably produces lesions of a sufficient size, number and configuration in an interior of the sphincter so as to create a selectable tightening of the sphincter.    
     
     
         2 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device includes a plurality of energy delivery members distributed on a surface of the expandable member.  
     
     
         3 . The apparatus of  claim 2 , wherein the plurality of energy delivery members are radially distributed along a surface of the energy delivery device expandable member.  
     
     
         4 . The apparatus of  claim 2 , wherein the plurality of energy delivery members are longitudinally distributed along a surface of the expandable member.  
     
     
         5 . The apparatus of  claim 1 , wherein the energy delivery device covers a portion of the surface of the expandable member.  
     
     
         6 . The apparatus of  claim 2 , wherein the energy delivery device covers substantially all of an exterior surface of the expandable member.  
     
     
         7 . The apparatus of  claim 1 , wherein the expandable member is sized to be positionable in a sphincter and to allow the energy delivery device to contact a portion of the inner surface of a sphincter.  
     
     
         8 . The apparatus of  claim 1 , wherein the expandable member is sized to be positionable in a sphincter and to allow the energy delivery device to contact all of an inner surface of the sphincter.  
     
     
         9 . The apparatus of  claim 1 , where the energy delivery device is sized to be positionable in the sphincter and non-permanently dilate the sphincter from a contracted state; and 
 wherein the sphincter returns to a pretreatment contracted state upon a removal of the expandable member from the sphincter.    
     
     
         10 . The apparatus of  claim 1 , wherein the lesions are formed in a muscle tissue underlying a sphincter mucosal layer.  
     
     
         11 . The apparatus of  claim 1 , wherein the sphincter is a lower esophageal sphincter.  
     
     
         12 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions at a fixed depth from a mucosal surface layer of the sphincter of no more than 4 mms.  
     
     
         13 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and minimizes injury to a mucosal and a submucosal layer of the sphincter.  
     
     
         14 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and reduces a frequency of sphincter relaxation.  
     
     
         15 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and reduces a duration of sphincter relaxation.  
     
     
         16 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and reduces a frequency of reflux of stomach contents into an esophagus.  
     
     
         17 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and reduces a frequency of a symptom of reflux of stomach contents into an esophagus.  
     
     
         18 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates the lesions and reduces an incidence of a sequela of reflux of stomach contents into an esophagus.  
     
     
         19 . The apparatus of  claim 1 , wherein the energy delivery device is positioned on an exterior surface of the expandable member.  
     
     
         20 . The apparatus of  claim 1 , wherein the energy delivery device is positioned on an interior surface of the expandable member.  
     
     
         21 . The apparatus of  claim 1 , further comprising: 
 a lumen positioned in an interior of the expandable member.    
     
     
         22 . The apparatus of  claim 1 , wherein the expandable member is expandable.  
     
     
         23 . The apparatus of  claim 1 , wherein the expandable member is a balloon.  
     
     
         24 . The apparatus of  claim 1 , wherein the expandable member is made of an expandable material.  
     
     
         25 . The apparatus of  claim 1 , wherein the expandable member is made of a porous material.  
     
     
         26 . The apparatus of  claim 1 , further comprising: 
 an electrolytic solution housed in an expanded expandable member.    
     
     
         27 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device delivers energy to promote a fibroblast cell infiltration at a site of the lesions.  
     
     
         28 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device delivers energy to promote a fibroblast growth at a site of the lesions.  
     
     
         29 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device delivers energy that promotes a mylofibroblast cell infiltration at a site of the lesions.  
     
     
         30 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates a tightening of a lower esophageal sphincter without permanently damaging anatomical structures near the lower esophageal sphincter.  
     
     
         31 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates a tightening of the lower esophageal sphincter without permanently damaging an aorta positioned near the lower esophageal sphincter.  
     
     
         32 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates a tightening of the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the lower esophageal sphincter.  
     
     
         33 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates a tightening of the lower esophageal sphincter without permanently damaging an esophageal plexus of nerves and veins positioned near the lower esophageal sphincter.  
     
     
         34 . The apparatus of  claim 1 , wherein the configuration of the energy delivery device creates a tightening of the lower esophageal sphincter while preserving a blood supply to the lower esophageal sphincter.  
     
     
         35 . The apparatus of  claim 1 , wherein the energy delivery device is an RF electrode.  
     
     
         36 . The apparatus of  claim 35 , further comprising: 
 an RF energy source coupled to the RF electrode.    
     
     
         37 . The apparatus of  claim 1 , wherein the energy delivery device is a microwave antenna.  
     
     
         38 . The apparatus of  claim 37 , further comprising: 
 a microwave energy source coupled to the microwave antenna.    
     
     
         39 . The apparatus of  claim 1 , wherein the energy delivery device is a waveguide.  
     
     
         40 . The apparatus of  claim 39 , further comprising: 
 a light source coupled to the waveguide.    
     
     
         41 . The apparatus of  claim 40 , wherein the light source is a laser.  
     
     
         42 . The apparatus of  claim 1 , wherein the energy delivery device is an acoustical transducer.  
     
     
         43 . The apparatus of  claim 1 , wherein the energy delivery device is a resistive heating device.  
     
     
         44 . The apparatus of  claim 1 , further comprising: 
 a visualization device coupled to the expandable member.    
     
     
         45 . The apparatus of  claim 1 , further comprising: 
 an extension member coupled to the expandable member.    
     
     
         46 . The apparatus of  claim 45 , wherein a proximal portion of the extension member is maneuverable by a medical practioner.  
     
     
         47 . The apparatus of  claim 1 , wherein the energy delivery device is a plurality of RF electrodes.  
     
     
         48 . The apparatus of  claim 47 , wherein the plurality of electrodes is a flexible circuit.  
     
     
         49 . The apparatus of  claim 1 , further comprising: 
 a mechanical expansion device coupled to the expandable member.    
     
     
         50 . An apparatus, comprising: 
 an expandable member means sized to be positionable in a lower esophageal sphincter and non-permanently dilate the lower esophageal sphincter from a contracted state;    an energy delivery device means coupled to the expandable member means, the energy delivery device means having a configuration that controllably produces lesions of a sufficient size, number and configuration in an interior of the lower esophageal sphincter to create a tightening of the lower esophageal sphincter; and,    wherein the lower esophageal sphincter returns to a contracted state upon a removal of the expandable member means from the sphincter.    
     
     
         51 . The apparatus of  claim 50 , wherein the energy delivery device means has a configuration that controllably produces lesions an interior of the lower esophageal sphincter without creating a permanent impairment of the lower esophageal sphincter's ability to achieve a physiologically normal state of closure.  
     
     
         52 . The apparatus of  claim 50 , wherein the energy delivery device is positioned on an exterior surface of the expandable member means.  
     
     
         53 . The apparatus of  claim 50 , wherein the energy delivery device is positioned on an interior surface of the expandable member means.  
     
     
         54 . The apparatus of  claim 50 , further comprising: 
 a lumen means positioned in an interior of the expandable member means.    
     
     
         55 . The apparatus of  claim 50 , wherein the expandable member means is expandable.  
     
     
         56 . The apparatus of  claim 50 , wherein the expandable member means is a balloon.  
     
     
         57 . The apparatus of  claim 50 , wherein the expandable member means is made of an expandable material.  
     
     
         58 . The apparatus of  claim 50 , wherein the expandable member means is made of a porous material.  
     
     
         59 . The apparatus of  claim 57 , further comprising: 
 an electrolytic solution means housed in an expanded expandable member means.    
     
     
         60 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means delivers energy to the interior of the lower esophageal sphincter and creates a fibroblast proliferation in the interior of the lower esophageal sphincter.  
     
     
         61 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means delivers energy to the interior of the lower esophageal sphincter and creates a myofibroblast proliferation in the lower esophageal sphincter.  
     
     
         62 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means creates a tightening of the lower esophageal sphincter without permanently disrupting an aorta positioned near the lower esophageal sphincter.  
     
     
         63 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means creates a tightening of the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the lower esophageal sphincter.  
     
     
         64 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means creates a tightening of the lower esophageal sphincter without permanently damaging an esophageal plexus of nerves and veins positioned near the lower esophageal sphincter.  
     
     
         65 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means creates a tightening of the lower esophageal sphincter while preserving a blood supply to the lower esophageal sphincter.  
     
     
         66 . The apparatus of  claim 50 , wherein the configuration of the energy delivery device means creates a tightening of the lower esophageal sphincter while creating submucosal lesions in the lower esophageal sphincter.  
     
     
         67 . The apparatus of  claim 50 , wherein the energy delivery device means is an RE electrode means.  
     
     
         68 . The apparatus of  claim 47 , further comprising: 
 an RF energy source means coupled to the RF electrode means.    
     
     
         69 . The apparatus of  claim 50 , wherein the energy delivery device means is a microwave antenna means.  
     
     
         70 . The apparatus of  claim 69 , further comprising: 
 a microwave energy source means coupled to the microwave antenna means.    
     
     
         71 . The apparatus of  claim 50 , wherein the energy delivery device means is a waveguide means.  
     
     
         72 . The apparatus of  claim 71 , further comprising: 
 a light source means coupled to the waveguide means.    
     
     
         73 . The apparatus of  claim 72 , wherein the light source means is a laser means.  
     
     
         74 . The apparatus of  claim 50 , wherein the energy delivery device means is an acoustical transducer means.  
     
     
         75 . The apparatus of  claim 74 , further comprising: 
 an acoustical energy source means coupled to the acoustical transducer means.    
     
     
         76 . The apparatus of  claim 50 , wherein the energy delivery device means is a resistive heating device means.  
     
     
         77 . The apparatus of  claim 50 , further comprising: 
 a visualization device means coupled to the expandable member means.    
     
     
         78 . The apparatus of  claim 50 , further comprising: 
 a extension member means coupled to the expandable member means.    
     
     
         79 . The apparatus of  claim 78 , wherein a proximal portion of the extension member means is maneuverable by a medical practioner.  
     
     
         80 . The apparatus of  claim 50 , wherein the energy delivery device means is a plurality of RF electrode means.  
     
     
         81 . The apparatus of  claim 80 , wherein the plurality of electrode means is a flexible circuit means.  
     
     
         82 . The apparatus of  claim 50 , further comprising: 
 a mechanical expansion device means coupled to the expandable member means.    
     
     
         83 . A method of treating a sphincter, comprising: 
 providing an expandable member sized to be positionable in the sphincter and configured to non-permanently open the sphincter from a contracted configuration, and an energy delivery device coupled to the expandable member;    introducing the expandable member in the sphincter;    dilating the sphincter from the contracted state;    delivering sufficient energy from the energy source to the sphincter to tighten the sphincter; and    removing the expandable member from the sphincter.    
     
     
         84 . The method of  claim 83 , wherein the energy delivery device has a configuration that controllably produces lesions an interior of the sphincter without creating a permanent impairment of the sphincter's ability to achieve a physiologically normal state of closure.  
     
     
         85 . The method of  claim 83 , wherein energy delivery device delivers sufficient energy to cause a proliferation of fibroblast cells in the sphincter.  
     
     
         86 . The method of  claim 85 , wherein the energy delivery device delivers sufficient energy to cause a proliferation of myofibroblast cells in the sphincter.  
     
     
         87 . The method of  claim 83 , wherein the energy delivery device delivers sufficient energy to create a tightening of the sphincter without permanently damaging anatomical structures near the sphincter.  
     
     
         88 . The method of  claim 87 , wherein the energy delivery device delivers sufficient energy to create a tightening of the sphincter without permanently disrupting an aorta positioned near the sphincter.  
     
     
         89 . The method of  claim 87 , wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of the lower esophageal sphincter without permanently damaging a vagus nerve positioned near the sphincter.  
     
     
         90 . The method of  claim 87 , wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of the lower esophageal sphincter without permanently damaging an esophageal plexus of nerves and veins positioned near the sphincter.  
     
     
         91 . The method of  claim 87 , wherein the energy delivery device delivers a sufficient amount of energy to create a tightening of the lower esophageal sphincter while preserving a blood supply to the sphincter.  
     
     
         92 . The method of  claim 83 , wherein the energy delivery device creates a tightening of the lower esophageal sphincter while creating submucosal lesions in the sphincter.  
     
     
         93 . The method of  claim 83 , wherein the expandable member is expandable.  
     
     
         94 . The method of  claim 73 , wherein the expandable member is introduced in the lower esophageal sphincter in an unexpanded state.  
     
     
         95 . The method of  claim 94 , wherein the expandable member is expanded to an expanded state when positioned in the sphincter.  
     
     
         96 . The method of  claim 93 , wherein the expandable member is a balloon.  
     
     
         97 . The method of  claim 93 , further comprising: 
 an electrolytic solution housed in an expanded expandable member.    
     
     
         98 . The method of  claim 83 , wherein the energy delivery device is an RF electrode.  
     
     
         99 . The method of  claim 98 , further comprising: 
 an RF energy source coupled to the RF electrode.    
     
     
         100 . The method of  claim 83 , wherein the energy delivery device is a microwave antenna.  
     
     
         101 . The method of claim  100 , further comprising: 
 a microwave energy source coupled to the microwave antenna.    
     
     
         102 . The method of  claim 83 , wherein the energy delivery device is a waveguide.  
     
     
         103 . The method of claim  102 , further comprising: 
 a light source coupled to the waveguide.    
     
     
         104 . The method of  claim 83 , wherein the light source is a laser.  
     
     
         105 . The method of  claim 83 , wherein the energy delivery device is an acoustical transducer.  
     
     
         106 . The method of claim  105 , further comprising: 
 an acoustical energy source coupled to the acoustical transducer.    
     
     
         107 . The method of  claim 83 , wherein the energy delivery device is a resistive heating device.  
     
     
         108 . The method of  claim 83 , wherein the energy delivery device is delivered to the sphincter transorally without an endoscope.  
     
     
         109 . The method of  claim 83 , wherein the energy delivery device is delivered to the sphincter with an endoscope.  
     
     
         110 . The method of  claim 83 , wherein the sphincter is the lower esophageal sphincter.

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